Validating high complexity lab test methods

High Complexity testing personnel regulations are much different than Non-Waived (Moderate) Complexity testing.In addition, depending on the State in which the laboratory is located, there may be additional State Licensure requirements.

That means method validation studies must now be performed for many methods that were previously exempted.We welcome any inquiries for LC/MS testing, as well as High or Moderate Complex Immunochemistry testing for Drugs of Abuse.Starting on April 24, 2003, all non-waived laboratory methods must be validated.For Microbiology subspecialties–bacteriology,mycobacteriology, mycology, virology, andparasitology:1. Licensed MD/DO/DPM, or Ph D AND Certifiedin clinical pathology 4 years training or experience in highcomplexity microbiology, with a minimum of6 months in subspecialty of testing.For immunology, chemistry, hematology,radiobioassay:1. Licensed MD/DO/DPM or Ph D AND Certifiedin clinical pathology 4years training or experience in the highcomplexity testing specialties performed. Licensed MD/DO/DPM AND Certified in Clinical Pathology OR 1 year lab trainingor experience in high complexity immunohematologytesting.1 year lab training/experience in highcomplexity testing.3.A second method validation must be performed on site by testing personnel using the "recipe" if you will presented in the procedure manual.

Point of Care (POC) testing for drugs of abuse is a qualitative method.

AA in lab science AND At least 2 years labtraining/experience in high complexity testing.4.

Education/training equivalent to AA degree,including: Graduation from a lab trainingprogram Have an additional 2 yearsof lab training/experience in high complexitytesting for either.5. 1, 1992, served as General Supervisor of high complexity testing andprior to 4/24/95 AND: Completed Military Medical Lab Specialist (50-week course) ORGraduated from an HHS-approved labtraining program more than 10years experience in high complexity testingplus a minimum of 6 years supervisoryexperience 9/1/82 - 9/1/92.6.

This includes methods that were previously exempted from validation. Westgard reviews the process and procedures of method validation.

Learn what experiments to perform, with how much data, and in what order.

Other options in replacing POC drugs of abuse testing is to acquire and install an Immunochemistry analyzer.

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